Design Verification Proposal: Food and Drug Administration ____________________________________________________________________________________________________________________________________________________________________________________________________________________________

Objective

To correctly map a biomedical product through development and write a proposal to the FDA for mock approval. Additionally, to familiarize ourselves with specific FDA guidelines and regulations.

Target Requirements

1) Overview current drug eluting and non-bio absorbing stents2) Highlight advantages of bio absorbing stents3) Timeline a development plan4) Highlight 6-12 month service and bio absorbing time5) Overview preliminary testing of different PHs and body

conditions6) Highlight contingency plan if material does not correctly form

into correct geometries for testing

Timeline overview of Ghantt Chart tasks and completion dates

Results

Initial peer rejection due to lack of depth within contingency plan and polymer forming techniques

Contingency plan modified to reflect more depth and possible solutions to problems

Polymer forming technique dismissed in favour of a more likely successful technique

Resubmission of proposal followed by acceptance

Recommendations

In the future identify critical paths in the project scope and address those critical paths sooner. By leaving the polymer forming section and contingency section vague lead to rejection even if the other sections were highly specific. Lastly, simplify processing techniques.

Poly-Lactic Acid Polymer test sample post design change. Initial design called for melting and forming into shape while the new technique involved no heat treating processes.Contact Info: aschader@calpoly.edu, Austin Schader